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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02338934 |
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Date of registration:
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11/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients
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Scientific title:
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An Open-label Study of Combination of Cinacalcet and Active Vitamin D Analogue in the Management of Severe Secondary Hyperparathyroidism in Haemodialysis Patients |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02338934 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Ong Loke Meng, FRCS |
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Address:
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Telephone:
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00 604 2225333 |
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Email:
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onglm@crc.gov.my |
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Affiliation:
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Name:
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Ong Loke Meng, FRCS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Research Centre, Penang Hospital, Malaysia |
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Name:
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Ong Loke Meng, FRCS |
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Address:
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Telephone:
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00 604 2225333 |
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Email:
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onglm@crc.gov.my |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:1. End Stage Renal Failure (ESRF) patients on haemodialysis with iPTH
levels more than 9x upper limit normal 2. Patients who has history of active Vitamin D
analogue doses limited by hypercalcaemia (>2.54 mmol/L)
Exclusion Criteria:
1. Pregnant or breastfeeding or planning to become pregnant
2. Life expectancy of 6 months or less
3. History of decompensated liver disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Secondary Hyperparathyroidism
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Intervention(s)
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Drug: Combination Cinacalcet with Vitamin D analogue
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Primary Outcome(s)
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Percentage reduction of iPTH levels from baseline at 6 months treatment
[Time Frame: 6 months]
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Secondary Outcome(s)
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The maximum iPTH reduction from baseline
[Time Frame: 24 months]
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Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit normal at 6, 12 and 24 months
[Time Frame: 24 months]
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Secondary ID(s)
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CT14-HPP-004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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